EP2698130B1 - Procédé de fabrication d'un implant corporel - Google Patents
Procédé de fabrication d'un implant corporel Download PDFInfo
- Publication number
- EP2698130B1 EP2698130B1 EP13003967.0A EP13003967A EP2698130B1 EP 2698130 B1 EP2698130 B1 EP 2698130B1 EP 13003967 A EP13003967 A EP 13003967A EP 2698130 B1 EP2698130 B1 EP 2698130B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- fiber material
- textile structure
- shaping
- fiber
- previous
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000007943 implant Substances 0.000 title claims description 35
- 238000004519 manufacturing process Methods 0.000 title claims description 15
- 239000002657 fibrous material Substances 0.000 claims description 210
- 239000004753 textile Substances 0.000 claims description 89
- 238000010438 heat treatment Methods 0.000 claims description 43
- 238000007493 shaping process Methods 0.000 claims description 34
- 238000000034 method Methods 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 28
- 239000000835 fiber Substances 0.000 claims description 16
- 238000009954 braiding Methods 0.000 claims description 15
- 238000012545 processing Methods 0.000 claims description 13
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 12
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 12
- 238000011282 treatment Methods 0.000 claims description 9
- 229910052751 metal Inorganic materials 0.000 claims description 7
- 239000002184 metal Substances 0.000 claims description 7
- 238000009940 knitting Methods 0.000 claims description 5
- 229910052755 nonmetal Inorganic materials 0.000 claims description 5
- 229920000642 polymer Polymers 0.000 claims description 5
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 claims description 5
- 229910052721 tungsten Inorganic materials 0.000 claims description 5
- 239000010937 tungsten Substances 0.000 claims description 5
- 229920002988 biodegradable polymer Polymers 0.000 claims description 4
- 239000004621 biodegradable polymer Substances 0.000 claims description 4
- 238000009941 weaving Methods 0.000 claims description 3
- 230000010354 integration Effects 0.000 claims 1
- 230000009466 transformation Effects 0.000 description 8
- 238000000576 coating method Methods 0.000 description 6
- 229910001566 austenite Inorganic materials 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 239000004033 plastic Substances 0.000 description 5
- 230000002441 reversible effect Effects 0.000 description 5
- 230000002792 vascular Effects 0.000 description 5
- 208000007474 aortic aneurysm Diseases 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 210000003709 heart valve Anatomy 0.000 description 4
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 229910000734 martensite Inorganic materials 0.000 description 4
- 238000000465 moulding Methods 0.000 description 4
- 239000011248 coating agent Substances 0.000 description 3
- 206010002329 Aneurysm Diseases 0.000 description 2
- 201000008982 Thoracic Aortic Aneurysm Diseases 0.000 description 2
- 208000002223 abdominal aortic aneurysm Diseases 0.000 description 2
- 230000006399 behavior Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 208000003457 familial thoracic 1 aortic aneurysm Diseases 0.000 description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 238000010348 incorporation Methods 0.000 description 2
- 210000005248 left atrial appendage Anatomy 0.000 description 2
- 230000003446 memory effect Effects 0.000 description 2
- 229930012538 Paclitaxel Natural products 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 206010038563 Reocclusion Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000012830 cancer therapeutic Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000002919 epithelial cell Anatomy 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 229960003444 immunosuppressant agent Drugs 0.000 description 1
- 230000001861 immunosuppressant effect Effects 0.000 description 1
- 239000003018 immunosuppressive agent Substances 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 229960001592 paclitaxel Drugs 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 238000007747 plating Methods 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- ZAHRKKWIAAJSAO-UHFFFAOYSA-N rapamycin Natural products COCC(O)C(=C/C(C)C(=O)CC(OC(=O)C1CCCCN1C(=O)C(=O)C2(O)OC(CC(OC)C(=CC=CC=CC(C)CC(C)C(=O)C)C)CCC2C)C(C)CC3CCC(O)C(C3)OC)C ZAHRKKWIAAJSAO-UHFFFAOYSA-N 0.000 description 1
- 229960002930 sirolimus Drugs 0.000 description 1
- QFJCIRLUMZQUOT-HPLJOQBZSA-N sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 1
Images
Classifications
-
- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
- D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
- D04C1/06—Braid or lace serving particular purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
-
- D—TEXTILES; PAPER
- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2509/00—Medical; Hygiene
- D10B2509/06—Vascular grafts; stents
Definitions
- the present invention relates to a method of manufacturing a body implant, such as a stent, a vascular support, a stent graft, a heart valve frame, an occluder, a flow diverter, or the like.
- a body implant such as a stent, a vascular support, a stent graft, a heart valve frame, an occluder, a flow diverter, or the like.
- Such body implants are made, for example, by creating textile structures from a material. It is difficult to combine the material of the textile structure with other materials, which would be desirable, for example, for introducing markers in the form of yarn or wire for increasing the radiopacity or the like.
- at least one of the materials should be provided with shape memory properties, for example by a so-called shape setting step.
- DE 696 24 834 T2 discloses a method of making a vascular prosthesis consisting of metallic and non-metallic yarns.
- the molding relied on plastic deformation molding.
- the pamphlets DE 696 24 834 T2 and DE 603 13 736 T2 directed.
- molding based on heat treatment is preferable to molding based on plastic deformation because plastic deformation is liable to damage the material. It was recognized that components in which the shape setting is ideally carried out by a heat treatment of at least metallic yarns, have different mechanical properties, as is the case with plastically deformed yarns.
- the fatigue behavior can be adversely affected by plastically deformed yarns.
- WO 00 / 44308A2 discloses woven intravascular devices and methods for their manufacture, and apparatus for their insertion.
- WO 2008/112242 A2 discloses a woven product having shape memory element filaments.
- this part can be replaced by a second one different fiber material to be replaced with different properties.
- the first fiber material can also be reused after a further processing step has been carried out, such as, for example, electropolishing and / or coating.
- the removal of the part of the fibers of the first material can be carried out, for example, by back braiding, for example by operating the braiding machine in the reverse direction, to remove a part of the fibers already embedded in the mesh back out of the mesh.
- the step "replacement by a second fiber material or wire or reinserting of the first fiber material after performing a further processing step on the removed part of the fibers of the first fiber material” follows a step of (re) generating the textile structure or a (new) textile structure.
- open is to be understood in particular that the braid is unbound again.
- An "opening” can be understood as a reversal or inverse process for producing a textile structure or a braid.
- a textile structure / braid can be opened by braiding it backwards.
- the first fibrous material when opened, is held in position.
- ends of the first fiber material may (still) remain fixed by means of holding devices such as grippers or wire, so that only the previous braiding process, namely the production of the first textile structure / braid, is reversed.
- a second fiber material or further fiber materials can then be "added", so that then a (new, second, modified) textile structure can be produced which comprises both first fiber material and second and optionally further fiber material.
- parts / fibers of the first fiber material can be removed before or after opening the (first) textile structure in one step.
- the textile structure may be subjected to a second shaping or heat treatment configured such that in the second forming only the second fibrous material is given a shape setting.
- a second shaping or heat treatment configured such that in the second forming only the second fibrous material is given a shape setting. This is achieved, for example, by carrying out a second heat treatment at a lower temperature and / or with a shorter duration of action than the first heat treatment.
- the second heat treatment thus leads to a shaping of the second fiber material, without influencing the shaping performed on the first fiber material during the first heat treatment.
- the second heat treatment on the second fiber material also be done separately prior to insertion of the second fiber material in the textile structure.
- the method further comprises the step of performing a second shaping or heat treatment on the second fiber material, wherein the second shaping or heat treatment is configured so that only the second fiber material is given a shape.
- a second heat treatment is performed at a lower temperature than the first heat treatment.
- the heat treatment is a shaping of the textile structure or the braid.
- the textile-processed fiber material is heated, for example, for a predetermined period of time to perform a shaping step. In this case, for example, incurred by the textile processing stresses in the fiber material are degraded or substantially eliminated.
- Nitinol may be a shape memory effect, such as many materials, i.a. Nitinol have. This means that first a metal structure is present in a so-called martensite structure, which is converted into an austenite structure by raising the temperature by phase transformation. What is unusual with Nitinol is that this transformation is reversible without plastic defects. The phase transformation takes place without diffusion, i. without the atoms changing places in the lattice structure.
- the atoms adopt an ordered twin arrangement by pure shear deformation.
- the second shaping or heat treatment is carried out on the textile structure produced from the two fiber materials or carried out separately prior to the insertion of the second fiber material.
- the textile structure is produced by textile processing, braiding, weaving, knitting or knitting.
- the textile structure or the braid can have at least a third fiber material.
- At least one of the fiber materials is electropolished and / or coated prior to final incorporation into the textile structure or the braid.
- This step may also be done after removal of a portion of the first fibrous material.
- a first shaping step is carried out by a first heat treatment and, after the removal of part of the fibers of the first fiber material, this part of the first fiber material is electropolished and / or coated and then re-incorporated into the textile structure.
- the first fibrous material comprises nitinol and the second or third fibrous material comprises one of a polymer, a biodegradable polymer, and tungsten.
- Nitinol is particularly suitable for generating Shape memory properties, for example, to expand a compressed body implant such as a stent after placement in the body due to the shape memory properties.
- tungsten can increase the radiopacity of a body implant.
- At least one of the fiber materials has shape memory properties.
- fibrous material may comprise one or more fibers and / or one or more wires and / or one or more yarns.
- a first fiber material can be formed from one or more fibers.
- a first fiber material can be formed from one or more yarns.
- a first fiber material can be formed from one or more wires. Analogous is also true for second, third, fourth, etc. fiber material.
- the second and / or further fibrous material may serve as an auxiliary material, e.g. to achieve a higher density.
- more than two fiber materials can be combined.
- a second and a third or fourth fiber material can be combined or intertwined.
- further fiber materials may be combined with the first and second fiber materials, wherein the fiber materials may have mutually different properties (strength, toughness, stiffness, bioresorbability, etc.).
- a textile structure can be produced that has a combination of shapes by connecting two or more textile structures together. It is possible to combine different materials, but also the same materials with the same or different previous processing steps.
- different preceding processing steps is to be understood, for example, that the fiber materials are subjected to different temperature treatments / were.
- a first and a second Fiber material may be made of the same material such as Nitinol, however, have been subjected to the first fiber material of a different heat treatment other than the second fiber material / be.
- the first fiber material may comprise different materials or treatments.
- the first fibrous material may comprise polymer threads / yarns as well as nitinol threads / wires.
- a second fiber material, which is combined with the first fiber material, in this case preferably has other material and / or treatment-related properties.
- a later-incorporated fiber material may leave a (main) structure to provide its own sequence structure.
- a textile structure can be formed with the combination of first and second fiber material, wherein (only) the second fiber material is led out or continued from this textile structure in order to form its own textile structure / sequence structure.
- a third fiber material may be led out of the (main) textile structure to form a sequential structure while the first and second fiber materials are not continued in the sequential structure.
- filter components or comparable components with an outer rigid structure for anchoring to the vessel and a more flexible inner part can be produced by the method provided.
- the first fibrous material is a heat treatable metal or a heat treatable nonmetal.
- the second fiber material is metal and / or nonmetal.
- the third fiber material or further fiber material of metal and / or non-metal is metal and / or nonmetal.
- the second fiber material is coated yarn or coated wire.
- the third and optionally further fiber materials of coated yarn or coated wire may comprise different yarns or wires and / or coatings.
- the second and / or the further fibrous material (s) may comprise different yarns / wire and / or coatings.
- the first fiber materials remain in the textile structure and an at least second fiber material is inserted.
- the second fiber material is made of the same material as the first fiber material, wherein the second fiber material has been subjected to a shape different from that of the first fiber material.
- the second fiber material comprises a second material different from the first fiber material. Additionally preferably, the second fiber material is subjected to the shape different from the first fiber material. The same applies to third, fourth, etc. fiber material.
- the second fiber material comprises the same material as the first fiber material, but the second fiber material has different properties from the first fiber material and / or was processed differently.
- the first fiber material and the second fiber material may be treated with mutually different heat treatments, such as an austenite finish (Af).
- the first and second fiber material may have different coatings from each other, such as gold plating, PTFE coating, etc .. The same applies to third, fourth, etc. fiber material.
- the second and / or further fiber material as a connecting element or connecting material between two textile structures , inserted / used.
- the second fiber material and / or a third, fourth, etc. fiber material can form a connecting element between at least two textile structures.
- a body implant such as a stent, a stent graft, a vascular support, a heart valve frame or the like can be manufactured, wherein the body implant has a textile structure or a mesh of a first fiber material and a second fiber material, wherein at least on the first fiber material a first heat treatment for forming a shape (Shape Setting) is performed.
- the body implant has at least two different fiber materials.
- one fiber material may be nitinol with shape memory properties and the other fiber material may be a material with good radiopacity, such as tantalum or gold.
- the body implant may also have a third and further different fiber materials. These may include polymers, biodegradable polymers, tungsten or the like.
- one of the above body implants is a vascular prosthesis.
- one of the above body implants is a stent graft.
- one of the above body implants is an occluder.
- one of the above body implants is a flow diverter.
- one of the above body implants is an aneurysm coil
- one of the above body implants is a heart valve frame.
- one of the above body implants is an abdominal aortic aneurysm (AAA) stent.
- AAA abdominal aortic aneurysm
- one of the above body implants is a thoracic aortic aneurysm (TAA) stent.
- TAA thoracic aortic aneurysm
- one of the above body implants is a gastroenterological stent.
- one of the above body implants is a peripheral stent.
- a braid as a textile structure 10 with a first fiber material 12 is generated.
- the first clapper 22 rotate counterclockwise and the second clapper 24 rotate clockwise.
- a body implant 1 can be produced in a tubular shape.
- a first heat treatment for producing a shaping of the first fiber material 12 is performed on the textile structure 10 or the braid.
- the first fiber material 12 for example, receives Nitinol, a shape memory property shaping to effect, for example, expansion after insertion of the body implant 1 into a living body.
- the heat treatment serves to shape the braid 10.
- the first fibrous material 12 subjected to textile processing is heated, for example, for a predetermined period of time to perform a shaping step. In this case, for example, resulting from the textile processing stresses in the first fiber material 12 are degraded or substantially eliminated.
- Nitinol may be a shape memory effect, such as many materials, i.a. Nitinol have. That is, first, there is a metal structure in a so-called martensite structure in the first fiber material 12, which is converted into an austenite structure by raising the temperature by phase transformation. What is unusual with Nitinol is that this transformation is reversible without plastic defects. The phase transformation thus takes place without diffusion, i. without the atoms changing places in the lattice structure.
- the atoms adopt an ordered twin arrangement by pure shear deformation.
- Fig. 4 shows the first fiber material 12 with the shaping carried out due to the first heat treatment step and a second fiber material 14, which has not yet undergone heat treatment. Accordingly, the first fibrous material 12 has a wave-like shape, for example, while the second fibrous material 14 has a straight wire or yarn shape.
- a portion of the first fibrous material 12 may be removed from the braid 10 by operating the braider 12 backwards, ie, the first bobbins 22, which rotate counterclockwise in normal operation, are now in a clockwise direction rotate, and the second clapper 24, which rotate clockwise in normal operation, are now rotated counterclockwise.
- the finished braid 10 consisting of the first fiber material 12 provided with the shaping step is partially opened.
- first fiber material 12 can now be reintroduced into the partially open braid 10 after a further treatment step has been carried out, for example, the first fiber material 12 can be electropolished or coated at nodes as a further treatment step.
- the portion of the first fibrous material 12 it may be electropolished and / or coated separately from the braid 10 to have a high quality. Thereafter, the part of the first fiber material 12 is re-integrated into the braid 10 by braiding.
- the further treatment step may also include a so-called “drug-eluting", i. coating with a medicament by dipping or spraying the first fibrous material 12 into, for example, a solution of the medicament.
- the medicament thus applied to the body implant 1 may be successively delivered there after being introduced into a human body.
- a so-called drug-eluting stent (DES) as body implant 1 may release small amounts of drugs that inhibit cell formation.
- Two drugs have become established in treatment with drug-eluting stents: the immunosuppressant sirolimus and the cancer therapeutic paclitaxel.
- Such stents can be used, for example, for the treatment of coronary heart disease.
- a second fiber material 14 with different properties can be incorporated.
- the first fibrous material 12 comprises nitinol
- the second fibrous material may be a polymer, a biodegradable polymer and / or tungsten.
- the braid 10 After incorporation of the second fibrous material 14, the braid 10 has both fibers of the first fibrous material 12 and fibers of the second fibrous material 14, as in FIG Fig. 5 is shown.
- a second shaping step may be carried out on the finished braid 10 on the finished braid 10 consisting of the first fiber material 12 with the already performed shaping and the second fiber material 14 without shaping.
- the second heat treatment should be configured such that the shape of the first fiber material 12 is substantially unaffected. This is achieved, in particular, by carrying out the second heat treatment at a lower temperature than the first heat treatment and / or over a shorter time than the first heat treatment.
- a braid 10a is produced from the first fibrous material 12, as shown in step a), and a first heat treatment is performed on the first fibrous material 12, as shown in step b).
- a braid 10b is produced from the second fiber material 14, as shown in step d
- a second heat treatment is performed on the braid 10b made of the second fiber material 14, as in FIG Step c) is shown.
- step e) of Fig. 6 is shown.
- This can be done, for example, by completely opening or releasing one of the previously produced braids 10a, 10b from the steps a, b or c, d and braiding it into the respective other braid 10b, 10a or a part of a braid 10a is removed and this part is replaced by the fiber material 14 of the other braid 10b.
- Fig. 7 schematically shows the production of a textile structure of a first fiber material combined with at least one second fiber material.
- step a the production of a textile structure 700 or a braid 700 from a first fiber material 712, and in step b) performing a first shaping of the textile structure or the braid, for example by a heat treatment and in step c) the production of a modified textile structure 716th from the first fiber material 712 combined with the at least second fiber material 714.
- Fig. 8 shows a schematic diagram of a textile structure with a mold combination 800 by two or more textile structures are joined together.
- a first textile structure 802 connected to a second textile structure 804.
- the second textile structure 804 is in turn connected to a third textile structure 806.
- These three interconnected textile structures form the mold combination 800.
- Fig. 9 shows a schematic diagram of a textile structure in which the second fiber material leaves the original textile structure and forms its own structure / shape.
- FIG. 9 shows a main structure 900 of later-bonded fiber material leaving the main structure 900 to provide its own sequence structure 902.
- a textile structure can be formed with the combination of first and second fiber material, wherein (only) the second fiber material is led out or continued from this textile structure in order to form its own textile structure / sequence structure.
- the main structure 900 may correspond to a textile structure 716, wherein in a further production step, for example, braiding, the following structure is produced.
- at least one (not shown) third fiber material can be woven into the braid 10 of the body implant 1.
- different heat treatments on the different fiber materials 12, 14 can be carried out in order to produce a shaping (shape setting).
- the braid 10 can obtain predetermined shape memory properties while exhibiting advantageous properties, for example, in terms of biocompatibility, biodegradability, or radiopacity.
- markers from a radiopaque material can be advantageously incorporated into the braid 10.
- the invention is not limited to braiding, but the textile structure 10 can also be produced by textile processing, weaving, knitting or knitting.
- the fiber material 12, 14 may also be a wire or a yarn.
- the invention is further not limited to the implementation on a braiding machine 20, but may also be performed by any other textile processing machine that can produce a corresponding textile structure.
- the method is not necessarily limited to body implants, but can be extended to all applications where it is necessary to realize a textile structure with two materials that must be heat treated (at least one material) but not simultaneously heat treated.
- a body implant according to the invention when inserted into a vessel, blood flow through the vessel can be improved.
- Incorporated fibers can affect, among other things, the flow behavior. This is e.g. used in the so-called flow diverters, in which the bloodstream is deflected and, for example, cuts off an aneurysm from the bloodstream.
- occlusions eg occluders for LAA (Left Atrial Appendage) or PFO (Patent Foramen Ovals) increase.
- LAA Left Atrial Appendage
- PFO Patent Foramen Ovals
- the formation of epithelial cells could be promoted. If a degradable material is used, the remaining metallic material can be reduced to a minimum. This could have a positive effect on the number of reocclusions, so-called re-stenosis.
- a body implant according to the invention can be better deformed and, in particular, expandable in a vessel.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Manufacturing & Machinery (AREA)
- Textile Engineering (AREA)
- Prostheses (AREA)
Claims (16)
- Procédé de fabrication d'un implant corporel (1) avec les étapes :génération d'une structure en textile (10) à partir d'au moins un premier matériau fibreux (12) ;réalisation d'un premier façonnage sur la structure en textile (10) ;élimination d'une partie des fibres du premier matériau fibreux (12), etremplacement par un deuxième matériau fibreux (14) et/ou réutilisation du premier matériau fibreux (12) après réalisation d'une autre étape de traitement sur la partie éliminée des fibres du premier matériau fibreux (12).
- Procédé de fabrication d'un implant corporel avec les étapes suivantes :génération d'une structure en textile (700) ou d'un tissage à partir d'un premier matériau fibreux (712) ;réalisation d'un premier façonnage sur la structure en textile (700) ou le tissage par exemple par un traitement thermique ;ouverture de la structure en textile (700) constituée du premier matériau fibreux (712) ;mise à disposition d'au moins un deuxième matériau fibreux (714) ; etfabrication d'une structure en textile modifiée (716) à partir du premier matériau fibreux (712) combiné avec l'au moins un deuxième matériau fibreux (714).
- Procédé selon la revendication 1 ou 2, en outre avec l'étape de la réalisation d'un second façonnage sur le deuxième matériau fibreux (14, 714), dans lequel le second façonnage est configuré de sorte que seul le deuxième matériau fibreux (14, 714) obtient un façonnage.
- Procédé selon la revendication 3, dans lequel le second façonnage est réalisé à une température plus basse que le premier façonnage.
- Procédé selon la revendication 3 ou 4, dans lequel le second façonnage est réalisé sur la structure en textile (10, 716) générée à partir des deux matériaux fibreux (12, 712 ; 14, 714) ou est réalisé séparément avant l'utilisation du deuxième matériau fibreux (14, 714).
- Procédé selon une des revendications précédentes, dans lequel la structure en textile (10, 700, 716) est générée par transformation de textile, tressage, tissage, tricot ou tricotage.
- Procédé selon une des revendications précédentes, dans lequel la structure en textile (10, 716) présente au moins un troisième matériau fibreux.
- Procédé selon une des revendications précédentes, dans lequel au moins un des matériaux fibreux (12, 712 ; 14, 714) est électropoli ou enduit avant le liage définitif dans la structure en textile (10, 716).
- Procédé selon une des revendications précédentes, dans lequel le premier matériau fibreux (12, 712) présente du nitinol et le deuxième (14, 714) et/ou troisième matériau fibreux présente un matériau parmi un polymère, un polymère biodégradable et du tungstène.
- Procédé selon une des revendications précédentes, dans lequel au moins un des matériaux fibreux (12, 712 ; 14, 714) présente des propriétés de mémoire de forme.
- Procédé selon une des revendications précédentes, dans lequel le premier matériau fibreux (12, 712) est un métal pouvant subir un traitement thermique ou un non-métal pouvant subir un traitement thermique.
- Procédé selon une des revendications précédentes, dans lequel le deuxième matériau fibreux (14, 714) et le troisième matériau fibreux sont en métal et/ou non-métal et/ou sont en fil enduit.
- Procédé selon une des revendications précédentes, dans lequel- le premier matériau fibreux (12, 712) est partiellement connecté au deuxième matériau fibreux (14, 714) et/ou au troisième matériau fibreux et- le deuxième matériau fibreux (14, 714) et/ou le troisième matériau fibreux forment une structure consécutive propre (902) après avoir quitté une structure principale (900).
- Procédé selon une des revendications susmentionnées, dans lequel le deuxième matériau fibreux (14, 714) présente le même matériau que le premier matériau fibreux (12, 712), et dans lequel le deuxième matériau fibreux (14, 714) a été soumis à un façonnage différent de celui au premier matériau fibreux (12, 712) et/ou présente différentes propriétés et/ou a été traité différemment.
- Procédé selon une des revendications susmentionnées, dans lequel le deuxième matériau fibreux (14, 714) présente un deuxième matériau différent du premier matériau fibreux (12, 712), et dans lequel le deuxième matériau fibreux (14, 714) a été soumis à un façonnage différent de celui au premier matériau fibreux (12,712).
- Procédé selon une des revendications précédentes, dans lequel le deuxième matériau fibreux (14, 714) et/ou le troisième matériau fibreux forment un élément de connexion entre au moins deux structures en textile (802, 804, 806).
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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DE102012016301A DE102012016301B3 (de) | 2012-08-16 | 2012-08-16 | Verfahren zum Herstellen eines Körperimplantats |
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EP2698130A1 EP2698130A1 (fr) | 2014-02-19 |
EP2698130B1 true EP2698130B1 (fr) | 2016-11-23 |
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EP13003967.0A Active EP2698130B1 (fr) | 2012-08-16 | 2013-08-08 | Procédé de fabrication d'un implant corporel |
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EP (1) | EP2698130B1 (fr) |
DE (1) | DE102012016301B3 (fr) |
ES (1) | ES2614482T3 (fr) |
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DE102014107113A1 (de) | 2014-05-20 | 2015-11-26 | Acandis Gmbh & Co. Kg | Medizinische Vorrichtung und System |
DE102014009920B4 (de) | 2014-07-03 | 2021-02-11 | Admedes Schuessler Gmbh | Verfahren zur Herstellung eines Körperimplantats und Werkzeug hierfür |
US8956394B1 (en) | 2014-08-05 | 2015-02-17 | Woven Orthopedic Technologies, Llc | Woven retention devices, systems and methods |
US9907593B2 (en) | 2014-08-05 | 2018-03-06 | Woven Orthopedic Technologies, Llc | Woven retention devices, systems and methods |
US20160074071A1 (en) | 2014-09-16 | 2016-03-17 | Woven Orthopedic Technologies, Llc | Methods of using woven retention devices and systems |
US20160168769A1 (en) * | 2014-12-12 | 2016-06-16 | Woven Orthopedic Technologies, Llc | Methods and systems for manufacturing woven retention devices |
CN104652036B (zh) * | 2015-03-24 | 2017-03-29 | 中国人民解放军国防科学技术大学 | 一种三维四向混编织物的制备方法 |
EP3331459A4 (fr) | 2015-08-05 | 2019-08-14 | Woven Orthopedic Technologies, LLC | Dispositifs, systèmes et procédés de prélèvement à utiliser dans un tissu osseux |
WO2018107114A1 (fr) | 2016-12-09 | 2018-06-14 | Woven Orthopedic Technologies, LLC. | Dispositifs de retenue, treillis et systèmes et procédés associés |
US10893931B2 (en) * | 2017-10-16 | 2021-01-19 | Amrita Vishwa Vidyapeetham | Strong, flexible, and thrombus-free woven nanotextile based vascular grafts, and method of production thereof |
DE102018108584A1 (de) * | 2018-04-11 | 2019-10-31 | Freistaat Bayern vertreten durch Hochschule Hof, Institut für Materialwissenschaften | Verzweigter Stent und Stentsystem |
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US5758562A (en) | 1995-10-11 | 1998-06-02 | Schneider (Usa) Inc. | Process for manufacturing braided composite prosthesis |
ATE311833T1 (de) * | 1999-02-01 | 2005-12-15 | Univ Texas | Gewebte intravaskuläre vorrichtung und verfahren zur herstellung |
US7018401B1 (en) | 1999-02-01 | 2006-03-28 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delivery of the same |
US20030135265A1 (en) * | 2002-01-04 | 2003-07-17 | Stinson Jonathan S. | Prostheses implantable in enteral vessels |
US7632299B2 (en) * | 2004-01-22 | 2009-12-15 | Boston Scientific Scimed, Inc. | Medical devices |
US8177834B2 (en) * | 2007-03-12 | 2012-05-15 | Cook Medical Technologies Llc | Woven fabric with shape memory element strands |
JP5751619B2 (ja) * | 2011-04-14 | 2015-07-22 | 朝日インテック株式会社 | ステント |
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US9416472B2 (en) | 2016-08-16 |
EP2698130A1 (fr) | 2014-02-19 |
ES2614482T3 (es) | 2017-05-31 |
DE102012016301B3 (de) | 2013-12-12 |
US20140035183A1 (en) | 2014-02-06 |
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